510(k) K103516

AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 by Inovise Medical, Inc. — Product Code DQD

K103516 is an FDA 510(k) premarket notification submitted by Inovise Medical, Inc. for the device "AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0". The FDA issued a decision of Substantially Equivalent on February 4, 2011. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Inovise Medical, Inc. has at least 10 other 510(k) clearances on record.